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Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a direct hire opportunity to work as a Quality Engineer located in Warren, NJ .

Shift: Monday-Friday, first shift; hybrid (3-4 days/week onsite)

Pay: $90k max (dependent on experience)

Job Overview:

The Quality Engineer is the subject matter expert for Software as a medical device SAMD and/or software as an accessory/component to a medical device, and ensures the software is compliant with all regulations. This role oversees implementation of the project quality management plan s and product plans of the organization. He/She helps to ensure the quality, compliance, and integrity of GXP systems used in the development, manufacturing, and distribution of medical devices / In vitro devices IVD . The role also manages projects from concept to completion; creates and manages project plan, work cross functionally to ensure completion, and ensure adequate training to impacted areas. He/She works effectively with stakeholders to ensure alignment with business objectives, correct prioritization, and successful project delivery and assists with product and process validations, including protocol and report review.

Key Accountabilities:

• Quality reviewer of software revision documentation, such as user acceptance testing and software testing/qualification.

• Work with software team during design updates.

• Ability to lead a cross-functional core team in successfully delivering to system-based projects and process improvements.

• Collaborate cross-functionally to create and execute project plans scope, schedule, staffing plans, quality, risk management, budget, and procurement and revise them appropriately to meet changing needs and requirements.

• Ensure that upgrades to medical device reagents and software are made in compliance with all applicable regulations.

• Support quality and regulatory teams in creating/revising technical documentation related to IVDs reagents and software and support deliverables required to meet country registration requirements.

• Monitor, analyze, and report on GXP system metrics and identify trends and areas for improvement.

• Support risk management practices and concepts and applies knowledge to manufacturing operations and software development.

• Support risk management program associated with commercial and development medical devices.

• Engage in the development and improvement of the internal manufacturing processes for existing and new products.

• Ability to simultaneously manage commercial and development projects.

• Update and maintain Design History Files / Technical documentation as needed.

• Including editing and review of impact and risk assessments for design, process, and risk control activities. Ensure integration of product regulatory requirements into product specifications and technical documentation.

• Partner with internal functional areas as part of the change control process.

• Support CAPAs and change control associated with product improvements.

• Support QA and RA on projects as needed.

• Quality Engineer/Medical Device/ IVD Software

  APPLY NOW FOR IMMEDIATE CONSIDERATION!!

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As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly ® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.